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Product was identified as potentially non-sterile as it received an underdose of gamma irradiation during the sterilization process. As the sterilization dose was not achieved, the sterility assurance level cannot be guaranteed. Recall start date:…

Non-licensed inventory was sent to Canada via web shop orders starting in February of 2022. Recall start date: December 12, 2022

Affected lots may contain the presence of foreign matter.

During internal studies with the Elecsys® Troponin T hs (high sensitive) and Elecsys® Troponin T hs Stat assays, it was confirmed that for certain k2/k3 EDTA primary tubes, TnT hs results are elevated compared to serum samples when measured…

Beckman Coulter has determined that the Access 2 wash arm lead screw nut band is susceptible to breakage. An Access 2 Immunoassay system wash arm may not move as intended if the nut band is broken. A broken nut band may increase the risk of erroneous…

BVI has received a complaint from a customer that catalog # 376630 of the Beaver Edgehead Stiletto/Mvr knife 0.90 mm Straight (20g), a component of the Readpak kit (cat:584896, lots:6054175,6053035), was shipped with an open head. BVI is recalling the…

There is a potential malfunction with the side-port of the Triever 24. The side-port may potentially leak or dislodge during device preparation or during actual use. The side-port of the triever24 catheter is used in combination with a 60cc large bore…

Summit Medical received a customer complaint that Nasal Septal Button, 5cm, SP-78105 parts received from lot# 219349 were in unsealed pouched. The product was sterilized, but if this sterile barrier is not sealed, there is a possibility of product…

Cardinal Health has initiated a medical device correction for specific production lots of the Cardinal Health™ Jackson-Pratt™ channel drains. The recall is being issued due to various performance issues including lack of radiopacity in wound drains, dull…

The manufacturer of Statis SL handpieces has informed SciCan that the product may not function as expected if not properly maintained. When using the Statis handpieces, the lack of care or age-related wear and tear could result in the loosening parts…

Manufacturer initiated recall notifying users of variability of only the level 1 troponin I values included in the Mas CardioImmune XL controls (confirmed after 8 complaints). The level 1 control is included in lots of control kits CAI-XL 1, CAI-XL4…

The catheter repair adhesive used to attach the repair segment to the original catheter is hardened/coagulated (unusable). Recall start date: January 4, 2023

Defective hard drives were identified in the graphical user interface tablet of some devices. The defective component leads to tablet screen freeze and reboot occurrences, eventually rendering the transcranial doppler (TCD) ultrasound system inoperable…

This recall is being initiated to address a potential risk associated with use of the Visiusmatrix 4.0 devices. We have identified that the hardware equipment racks of the Visiusmatrix 4.0 devices at customer sites have not undergone all required aspects…

The recall is due to quality complaints from health care professionals that the gloves may not meet their intended use in a medical/surgical setting. The gloves easily tear and may result in potential harm, including contamination and disease…